Kornimate/medical-research-clean huggingface dataset:
a study investigating the predictive value of philadelphia positive stem cell properties in newly diagnosed patients with chronic myeloid leukemia in chronic phase receiving treatment with imatinib

Conditions: Chronic Myeloid Leukemia

Summary: imatinib (im) is first-line treatment for patients with newly diagnosed cml in chronic phase. the drug is associated with high rates of cytogenetic responses with minimal toxicity in approximately 80% of patients. in 20% of patients however, the disease is either initially unresponsive to im (imatinib), resistance develops within a few months, or blast crisis occurs early and unexpectedly following an initial response. an increasing body of clinical evidence indicates that single agent molecularly targeted therapy (as in gleevec/imatinib) will not cure most patients with cml, as molecular remissions are rare. there is currently no clinically useful predictive tests to identify at diagnosis those patients who are destined to be im failures. the authors of this study have recently demonstrated that cml stem/progenitor cells are biologically insensitive to im and are also genetically unstable and rapidly generate im-resistant mutants in vitro and in vivo. the team recently discovered that the cd34 stem/progenitor cells of newly diagnosed cml patients who subsequently fail to respond to im treatment show a reduced response to im and a higher frequency of bcr-abl mutations by comparison of 14 im non-responders with 11 im-responders. if this finding can be validated in a larger prospective cohort of patients, this predictive test could be used to more rationally design treatment plans with early addition of alternative therapies ie: dasatinib or combination therapies for patients according to their individual risk profiles. hypothesis: the clinical response of newly diagnosed chronic phase cml patients to im can be predicted by certain biological properties of their cd34 stem/progenitor cells which are variable among patients.


Eligibility criteria:
inclusion criteria: * diagnosis of cml in chronic phase. * ecog \<2. * normal organ function and uln total bili, ast and alt. * must have the ability to understand and sign a written consent form exclusion criteria: * patients may not be receiving any other investigational agents. * may not have prior treatment with imatinib, dasatinib, nilotinib or other tyrosine kinase inhibitors. * patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or nursing mothers * patients must have no prior malignancies except for; adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated stage i or ii cancer from which the patient is in complete remission, or any other cancer from which the patient has been disease free for 5 years

Keywords: cml predictive study
amplifying graft-versus-tumor effect by donor regulatory t-cell depletion before donor lymphocytes infusion

Conditions: Hematologic Neoplasms; Relapse

Summary: the investigators have previously shown that depletion of cd4+cd25+foxp3+ regulatory t cells (treg) enhances the alloreactivity of t lymphocytes, as attested by an accelerated gvhd after allogeneic hematopoietic stem cell transplantation (hsct) in mice. the investigators thus propose a clinical trial to test whether treg-depleted donor lymphocytes infusion (ddli) could induce an improved graft-versus-tumor (gvt) effect in patients refractory to standard dli (stddli) for treatment of relapse after hsct.

we have previously shown that depletion of cd4+cd25+foxp3+ regulatory t cells (treg) enhances the alloreactivity of t lymphocytes, as attested by an accelerated gvhd after allogeneic hematopoietic stem cell transplantation (hsct) in mice. we thus propose a clinical trial to test whether treg-depleted donor lymphocytes infusion (ddli) could induce an improved graft-versus-tumor (gvt) effect in patients refractory to standard dli (stddli) for treatment of relapse after hsct. ddli is administered after failure of 1 or several previous stddli of at least 107 cd3+ cells/kg, defined after a minimal follow-up of 2 months after the last injection. the absence of previous clinical manifestations of gvhd is required to be included. to prepare ddli, cd25+ treg are depleted from donor leukaphereses using anti-cd25 magnetic microbeads and a clinimacs device (myltenyi). in order to evidence the potential effect of ddli, the ddli cell dose is adjusted to be below or equal to the maximal cell dose previously received in stddli. no comparison is planned in the analysis.

Eligibility criteria:
inclusion criteria: * hematological malignancy except chronic myeloid leukaemia. * previous allogeneic hematopoietic stem cell transplantation. * relapse diagnosed at the molecular, cytogenetic, or cytological level. * failure of a previous stdild or inclusion in first intention if progressive disease. * age \> 18 years and \< 70 years at the time of inclusion. * performance status considered on the score ecog \< 2. * life expectation 1-month-old superior. * signed written informed consent. * negative hcg in the 7 days preceding the inclusion for women in age of procreation. * membership of the french national insurance. exclusion criteria: * chronic myeloid leukemia * grade \>ii acute gvhd or chronic extensive gvhd at the time of inclusion. * patient receiving an immunosuppressive treatment for gvhd treatment at the time of inclusion. * dysfunction of liver (alat/asat \> 5 n, or bilirubin \> 50 µm), or of the renal function (creatinine clearance \< 30 ml / min).

Keywords: hematological malignancy allogeneic hematopoietic stem cell transplantation donor lymphocyte infusion antitumor immunotherapy graft-versus-tumor effect regulatory t cells adult
endovascular aneurysm repair (evar) gate study

Conditions: Abdominal Aortic Aneurysm (AAA)

Summary: this study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair (evar) procedure. this information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure.

endografts currently fda-approved for abdominal aortic aneurysm (aaa) repair are modular systems,comprised of a main body (aortic trunk) and two legs (ipsilateral leg endoprosthesis and a contralateral leg endoprosthesis). in placement of the endograft the main body and ipsilateral limb are deployed from a retrograde common femoral artery approach. from the contralateral femoral artery, cannulation of the contralateral gate is required to deploy the contralateral iliac limb.cannulation of the contralateral limb gate is the portion of the operation that requires the most "wire skills." depending on the patients' body type, angulations of the aorta and the size and volume of the aaa, this portion of the procedure can be technically difficult. this portion may become lengthy and discouraging if the surgeon fails to cannulate the gate using a particular approach. cannulation of the contralateral limb gate from a retrograde femoral artery approach is commonly achieved by first using a maneuverable guidewire and steerable catheter. antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. the wire may be retrieved on the contralateral limb using a snare device. the problem and why it is important -- difficulty in accessing the contralateral gate leads to increase procedural time and excess exposure to radiation. the standard of care is retrograde cannulation with the use of crossover snare techniques as a secondary adjunct if retrograde cannulation fails. in this study we will compare retrograde cannulation to primary snaring.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * patient is undergoing evar repair with a commercially available endograft * willing to give consent * procedure is elective exclusion criteria: * declines to participate * unable to provide consent * urgent aaa repair * participating in another study

Keywords: snare technique cannulation of contralateral gate endovascular aneurysm aaa abdominal aortic aneurysm
cognition and qol after thyroid surgery

Conditions: Thyroid Nodule; Thyroid Cancer; Cognitive Decline; Survivorship; Symptoms, Cognitive

Summary: the development of cognitive dysfunction can profoundly affect hr-qol as well as the possibility of societal participation and ability to work, and thereby relevantly impacts prospects for cancer survivorship. the aim of the study is to obtain improved understanding of the scope and magnitude of objective cognitive dysfunction in dtc survivors, and its relation to subjective cognitive dysfunction, thyroid hormone levels, physical activity and hrqol. this is done in a prospective study where patients operated for a thyroid nodule (bethesda iv-vi, i.e., benign \[goitre with nodule and fibroadenomas\], low-risk dtc and intermediate-high risk dtc) are included and asked to serially perform online neuropsychological testing as well as to complete questionnaires related to hr-qol, physical activity and additional psychological and physical complaints. blood is analysed for levels of thyroid hormones and systemic inflammation.

the primary aim of this study is to prospectively assess objective cognitive functioning in patients undergoing thyroid surgery for different indications by means of an online neuropsychological test, the amsterdam cognition scale (acs). three patient groups are defined; 1) patients with follicular adenomas, 2) patients with extreme low-risk differentiated thyroid cancer (dtc; pt1a and pn0/x tumours), 3) patients in all other dtc risk groups (i.e., low, intermediate and high-risk). the primary comparison confers to groups 1 and 3.

Eligibility criteria:
inclusion criteria: * age \>18 years old, indication for surgery because of a thyroid nodule bethesda iv-vi * able to read and understand the swedish language * access to desktop computer or laptop with internet connection * able and willing to provide written informed consent exclusion criteria: * a previous diagnosis of (auto-immune) hypothyroidism * a previous cancer diagnosis (excluding basal cell cancer of the skin) * indications for surgery other than (solely) a thyroid nodule (i.e., concomitant graves) * a diagnosis of medullary and anaplastic thyroid cancer
sensimed triggerfish in closed eyes

Conditions: Glaucoma

Summary: this study investigates the effect of eye opening/closure on the quality of iop (intraocular pressure) related patterns recorded with sensimed triggerfish. each subject receives 2 24-hour recording sessions, one with the recorded eye open and the other with the eye closed,using an ophthalmic patch.


Eligibility criteria:
inclusion criteria: * healthy subject without previous ophthalmic medical history (except from indication for glasses) * aged ≥18 years, of either sex * have given written informed consent, prior to any investigational procedures exclusion criteria: * patients with allergy to corneal anesthetic * patients with contraindications for silicone contact lens wear * patients not able to understand the character and individual consequences of the investigation * participation in other clinical research within the last 4 weeks
do patients with early post operative recurrence of pelvic organ prolapse have a genetic predisposition?

Conditions: Pelvic Organ Prolapse

Summary: the objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.

pelvic organ prolapse develops as a result of a loss of support provided by the muscles and fascia that constitute the pelvic floor. several recent population studies have estimated the prevalence of pelvic organ prolapse at between 10% and 30%. one in nine women will undergo surgery for these disorders in her lifetime and of these, one third will undergo repeated surgeries. the correction of pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patients quality of life. there are a few studies that have explored the genetic predisposition to developing pelvic organ prolapse but none so far looks at genetic factors involved in prolapse recurrence after adequate prolapse repair. there are two groups of women: women who underwent adequate repair of their prolapse and had an unexplained early recurrence. and a second control group of women who underwent the same prolapse repair procedure and had no further prolapse recurrence.

Eligibility criteria:
inclusion criteria: * cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery) exclusion criteria: * obvious surgical technical failure * use of other graft material than polypropylene mesh * planned two staged operation * contraindications to surgery based on existing medical conditions * pregnancy * desire for pregnancy in the future

Keywords: pelvic organ prolapse recurrence of pelvic organ prolapse genetic predisposition snp microarray analysis pelvic floor genetic factors adequate prolapse repair polymorphisms surgical failure reoperation dna buccal swabs taqman snp allelic discriminiation assays duplex real-time pcr genome-wide snp microarrays next-generation sequencing
evaluation of sound processor for a transcutaneous system

Conditions: Conductive Hearing Loss; Mixed Hearing Loss

Summary: a single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.

bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. the sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. this evaluation focus on a sound processor used for a transcutaneous system.

Eligibility criteria:
inclusion criteria: * subjects implanted with the bridging bone conductor (bbc) implant * subjects that have completed one year follow up in osseofon bci (bone conduction implant) study * subjects available for 6 months study procedures without affecting the follow ups in the osseofon bci study * active user of the bci sp exclusion criteria: * inability to participate in follow-ups * unsuitable as judged by the principle investigator or the sub-investigator
research study investigating how well semaglutide works in people suffering from overweight or obesity

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this study will look at the change in participant's body weight from the start to the end of the study. this is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. in addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. the participant will get semaglutide for the first 20 weeks. then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. the participants will need to take 1 injection once a week. the study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. the study will last for about 1.5 years.


Eligibility criteria:
inclusion criteria: * male or female, age greater than or equal to 18 years at the time of signing informed consent * body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm with the presence of at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * history of at least one self-reported unsuccessful dietary effort to lose body weight exclusion criteria: * haemoglobin a1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening * a self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
belgian mitraclip registry

Conditions: Mitral Valve Insufficiency

Summary: the primary objective of the registry is to investigate and follow all patients treated with the mitraclip system in belgium. this information is intended to contribute to decision making with regards to mitraclip therapy selection in patients with mitral regurgitation: (a) by establishing the clinical value of the mitraclip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers/government in making coverage decisions. in addition national data will be shared with european registries in order to increase the knowledge about the efficacy of this new technique.


Eligibility criteria:
inclusion criteria: * severe mitral regurgitation * symptomatic (nyha class\>1) despite optimal medical therapy * suitable anatomy for mitraclip implantation * too high risk for cardiac surgery exclusion criteria: * \<1 year life expectancy
urine-based detection of non-muscle invasive bladder

Conditions: Bladder Cancer

Summary: non-muscle invasive bladder cancer (nmibc), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. uromonitor is a completely non-invasive urine based ivd diagnosis test. it´s able to detect non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. regardless of tumor stage and grade (unlike cytology). the rate of uromonitor false positives (2,3%) is actually lower than the rate of cystoscopy false positives (3,5%).

non-muscle invasive bladder cancer (nmibc), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. uromonitor is a completely non-invasive urine based ivd diagnosis test. it´s able to detect non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. regardless of tumor stage and grade (unlike cytology). the rate of uromonitor false positives (2,3%) is actually lower than the rate of cystoscopy false positives (3,5%). hypothesis: the study aims at evaluating the potential clinical impact of a highly sensitive urinary marker, uromonitor, regarding possible reduction in number of cystoscopies. we hypothesize that the use of a sensitive urinary marker regarding recurrent tumor will enable us to reduce the number of follow-up cystoscopies without risk of delaying diagnosis of recurrence and progression cystoscopies compared to flexible cystoscopy alone. we hypothesize that number of tumors missed at follow-up cystoscopy alone or urinary marker alone is identical or in favor of a sensitive urinary marker that can detect sub-visible lesions and the examinations combined identify all tumor recurrences. moreover, we hypothesize that tumors missed at follow-up at a given time point are very small and will be identified at next follow-up without increasing the risk of progression and that regular follow-up with cystoscopy alone therefore can be replaced by follow-up with a sensitive urinary biomarker alone - where cystoscopy only is performed if the biomarker is positive.

Eligibility criteria:
inclusion criteria: * patients who previously had low grad nmibc. * subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. exclusion criteria: * clinical suspicion of muscle invasive bladder cancer * upper urinary track tumours * patients undergoing neoadjuvant chemotherapy based on local protocols * metastatic urothelial carcinoma * patients recived installation therapy within the last 4 weeks
lidocaine spray vs viscous lidocaine solution plus lidocaine spray in patients undergoing non-sedated egd

Conditions: Pain; Satisfaction, Patient

Summary: this study aimed to compare the efficacy of lidocaine spray (s) alone versus lidocaine spray combined with lidocaine viscous solution (s+v) in facilitating pharyngeal observation during non-sedating upper gastrointestinal endoscopy (uge).

a randomized controlled trial was conducted between july and october 2023 at sawanpracharak hospital, thailand. of 250 patients undergoing uge, 125 were randomly assigned to group s (lidocaine spray alone) and 125 to group s+v (lidocaine spray plus lidocaine viscous solution). the total dose of lidocaine did not exceed 5 mg/kg in both groups

Eligibility criteria:
inclusion criteria: * patients scheduled for upper gastrointestinal endoscopy: * patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (american society of anesthesiologists (asa) physical status classification i-ii). exclusion criteria: * has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy. * has a history of post-endoscopy nausea and vomiting. * patients who have undergone upper gastrointestinal endoscopy previously. * has chronic conditions such as epilepsy, vertigo, or mental health disorders. * has a history of allergy to anesthesia used in the study. * pregnant or currently breastfeeding. * refuses to participate in the study.

Keywords: lidocaine spray lidocaine solution non-sedating egd
national survey on the lockdown of children with disabilities

Conditions: Identify Emerging Health Challenges for Children With Motor Disabilities and Their Parents Facing the COVID-19 Pandemic

Summary: during the covid-19 pandemic, lockdown measures were established in france affecting the life course of children with disabilities. this study aimed at identifying the experiences, main difficulties and needs of these children and their parents during the lockdown period.


Eligibility criteria:
inclusion criteria: -children (age 0-18 years) with motor disabilities (with and without associated impairement), living in france. exclusion criteria: -